Standard Operating Procedure for Uniformity Testing of Multiple-Layered Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/090/2025 |
| Supersedes | SOP/TAB/090/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To outline the procedure for testing the uniformity of multiple-layered tablets, ensuring that each layer of the tablet contains the correct amount of active pharmaceutical ingredient (API) and excipients.
2. Scope
This SOP applies to uniformity testing of multiple-layered tablets in the manufacturing process to ensure consistent API distribution across all layers, ensuring product quality and compliance with regulatory standards.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing the multiple-layered tablet samples for testing and ensuring proper handling and storage of the tablets.
- Quality Control (QC): Responsible for conducting uniformity testing, recording the results, and ensuring the uniformity of API distribution within the tablets.
- Quality Assurance (QA): Ensures the testing procedure is followed correctly and reviews the results to approve or reject the batch for release.
4. Accountability
The QC Manager is accountable for ensuring the uniformity testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and approving the batch for release.
5. Procedure
5.1 Sample Collection
- Collect a representative sample of multiple-layered tablets from the batch, as specified in the batch record.
- The sample should consist of a minimum of 6 tablets, or as specified in the batch record or pharmacopeial guidelines.
- Ensure that the tablets are free from defects such as cracks, chips, or contamination.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Testing Apparatus
- Ensure that all required equipment (e.g., analytical balance, cutting tools, sample containers) is clean and calibrated according to company SOPs.
- Prepare the apparatus for testing according to the method specified in the pharmacopeial guidelines or batch record.
5.3 Performing the Uniformity Test
- Use a sharp blade or a tablet splitter to cut each tablet into its respective layers, ensuring a clean and accurate cut for analysis.
- Weigh each layer separately using a calibrated analytical balance. Record the weight of each layer in the batch record (Annexure-1).
- If using content uniformity testing, sample each layer from the tablet and dissolve it in an appropriate solvent.
- Perform the assay of the API content in each layer using a suitable analytical method, such as High-Performance Liquid Chromatography (HPLC), following the procedure outlined in the batch record or pharmacopeial guidelines.
5.4 Data Recording and Calculation
- Record the weight of each layer or assay results in the batch record (Annexure-1).
- Ensure that the API content in each layer is within the acceptable limits specified in the batch record or pharmacopeial guidelines.
- Calculate the content uniformity by comparing the API content in each layer with the expected range for each layer’s API dose.
5.5 Acceptance Criteria
- Ensure that the API content in each layer meets the acceptance criteria for uniformity, which typically requires the content to be within ±10% of the target API concentration for each layer.
- If any layer fails to meet the specified API content, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).
5.6 Documentation and Record-Keeping
- Document all test results, including the weight of each layer, assay results, and any observations, in the batch record (Annexure-1).
- Record any deviations from the acceptance criteria in the deviation report (Annexure-2), along with corrective actions taken.
- Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
5.7 Post-Test Cleanup
- Clean all equipment used for uniformity testing, including sample containers, cutting tools, and balances, according to the cleaning SOP to prevent contamination between tests.
- Ensure that the laboratory equipment is properly stored and maintained in good working condition.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- HPLC: High-Performance Liquid Chromatography
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <905> – Uniformity of Dosage Units
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Uniformity Testing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Record
| Batch Number | Tablet Sample | Layer | Weight (g) | API Content (%) | Result |
|---|---|---|---|---|---|
| Batch 001 | Multiple-Layered Tablet | Layer 1 | 1.0 | 98.5% | Pass |
| Batch 001 | Multiple-Layered Tablet | Layer 2 | 1.0 | 99.2% | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 10/12/2025 | Batch 001 | API content variation in Layer 2 | Adjusted formulation and reworked blending process | Jane Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Testing Procedures | Refined API content uniformity testing | QA Head |